Inpatient Facililty DiagnosesNCT03697915
Implementing Lift System for Early Mobilization
A study testing Experimental in people with Inpatient Facililty Diagnoses, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Objective:Immobilization causes various physiological and biomechanical problems during inpatient treatments.Physical therapy is applied to achieve early mobilization and avoid complication of immobilization. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Inpatient Facililty Diagnoses
- What is being tested?
- Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2018to 8 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergone surgical procedures leading to immobilisation
- having a disease affecting the musculoskeletal system
- being conscious and not having sitting balance.
Who cannot join
- co-operation, orientation
- cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial
Objective:Immobilization causes various physiological and biomechanical problems during inpatient treatments.Physical therapy is applied to achieve early mobilization and avoid complication of immobilization.
Aim:The aim of this study is to assess the contribution of using lift system to physical therapy program of immobilized patients.
Read more
Design:A randomised controlled trial. Patients:Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups.
Interventions: Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.Patients allocated to the add-on lift system were held in upright position with James lift® system during each physical therapy(PT).Patients allocated to PT program only were upgraded to a therapeutic goal of stability during standing phase as the patient's muscular strength improved.
Read the detailed description
In this study, 30 patients aged 50-75 years who were immobilised for >1 week and were conscious but did not have sitting balance were evaluated. Before this study was initiated, approval was obtained from the XXX University Ethics Committee (number 2018-40016-46, dated 24/04/2018). The inclusion criteria for the study included having undergone surgical procedures leading to immobilisation or having a disease affecting the musculoskeletal system, being conscious and not having sitting balance. The exclusion criteria included co-operation, orientation and cognitive impairment.
Patients were divided into two groups: control group, in which a conventional physical therapy programme was applied, and experimental group, in which a physical therapy programme supplemented by the James lift system was applied. Randomisation was performed according to the hospitalisation order of the patients.
Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase.
In addition to the conventional treatment programme in the experimental group, orthostatic blood pressure was checked at the early stage before the patients gained sitting balance. Once the patients gained standing balance using the lift, they were administered walking training.
Conventional physical therapy was administered to both the groups and included passive and active assisted joint range of motion exercises, sitting balance, standing balance, electrotherapy (20 min of electrical stimulation on bilateral quadriceps and muscles) and ambulatory training.
Pre- and post-treatment evaluations included age, height, weight, duration of hospital stay and day of initial mobilisation. Clinical and Rivermead mobility indices were used as the primary outcome. The Barthel index, which assesses daily living activities, and hospitalisation period were evaluated as secondary outcomes.
The James 150 lift system is a hydraulic system made of steel pipes with a carrying capacity of 150 kg and is designed to keep the patients in an upright position. It is a hydraulic transport system with a short installation time, including an electric lift arm, 24-Volt motor, wired remote control, emergency button, mechanical emergency lowering, extensible undercarriage pedal, swivel castors and rear-wheel brakes. When a patient is required to be switched to the upright position, he/she is supported by Velcro sheaths in the thoracolumbar area, knees are locked with knee supports, feet are switched to the dorsiflex position using the foot pedal and the patient is brought to the upright position. During this time, the patient grips the lift handles with his/her hands for support. The patient is protected against falling during the lifting process by the brake-lock system.
The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility.
The clinical mobility scale evaluates the level of mobility and is scored between 0 and 3 points. It includes the following items: upright posture, walking, gait, sitting, stair climbing, hand-held appliances and wheelchair and time usage. It is scored between 0 and 24 points, and higher scores indicate increased mobility.
The Barthel index scores daily life activities. The total score can range between 0 and 100 points, with each question score ranging from 0.5 to 10 points. The sub-topics covered include feeding, bathing, grooming, dressing, bowel care, bladder care, toilet use, transfer (bed to chair and back), mobility (on levelled surfaces) and stair climbing. Higher scores indicate improved independence of the patient.
- Conditions
- Inpatient Facililty Diagnoses
- Being tested
- Experimental
- Keywords
- Lift system, Early mobilization, Immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDevice
Also called Control
Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group, in which a physical therapy programme supplemented by the James lift system was applied Receives: Device: Experimental |
| Control | Placebo comparator | Control group, in which a conventional physical therapy programme was applied. Receives: Device: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility index
The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility
Measured: 1 minute
Secondary outcomes (1)
Daily life activities
The Barthel index scores daily life activities. The total score can range between 0 and 100 points, with each question score ranging from 0.5 to 10 points. The sub-topics covered include feeding, bathing, grooming, dressing, bowel care, bladder care, toilet use, transfer (bed to chair and back), mobility (on levelled surfaces) and stair climbing. Higher scores indicate improved independence of the patient
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start2 Jun 2018
- Primary completion25 Sep 2018
- Study completion8 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inpatient Facililty DiagnosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups. Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- Tomri̇s Duymaz, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697915
- Sponsor's protocol ID
- 2018-40016-46
- Other IDs
- 2018
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03697915
- Acronym / sponsor ID
- 2018-40016-46
- Conditions
- Inpatient Facililty Diagnoses
- Keywords
- Lift system, Early mobilization, Immobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 8 Oct 2018 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:Immobilization causes various physiological and biomechanical problems during inpatient treatments.Physical therapy is applied to achieve early mobilization and avoid complication of immobilization.
Aim:The aim of this study is to assess the contribution of using lift system to physical therapy program of immobilized patients.
Design:A randomised controlled trial. Patients:Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups.
Interventions: Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.Patients allocated to the add-on lift system were held in upright position with James lift® system during each physical therapy(PT).Patients allocated to PT program only were upgraded to a therapeutic goal of stability during standing phase as the patient's muscular strength improved.
Detailed description
In this study, 30 patients aged 50-75 years who were immobilised for >1 week and were conscious but did not have sitting balance were evaluated. Before this study was initiated, approval was obtained from the XXX University Ethics Committee (number 2018-40016-46, dated 24/04/2018). The inclusion criteria for the study included having undergone surgical procedures leading to immobilisation or having a disease affecting the musculoskeletal system, being conscious and not having sitting balance. The exclusion criteria included co-operation, orientation and cognitive impairment.
Patients were divided into two groups: control group, in which a conventional physical therapy programme was applied, and experimental group, in which a physical therapy programme supplemented by the James lift system was applied. Randomisation was performed according to the hospitalisation order of the patients.
Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase.
In addition to the conventional treatment programme in the experimental group, orthostatic blood pressure was checked at the early stage before the patients gained sitting balance. Once the patients gained standing balance using the lift, they were administered walking training.
Conventional physical therapy was administered to both the groups and included passive and active assisted joint range of motion exercises, sitting balance, standing balance, electrotherapy (20 min of electrical stimulation on bilateral quadriceps and muscles) and ambulatory training.
Pre- and post-treatment evaluations included age, height, weight, duration of hospital stay and day of initial mobilisation. Clinical and Rivermead mobility indices were used as the primary outcome. The Barthel index, which assesses daily living activities, and hospitalisation period were evaluated as secondary outcomes.
The James 150 lift system is a hydraulic system made of steel pipes with a carrying capacity of 150 kg and is designed to keep the patients in an upright position. It is a hydraulic transport system with a short installation time, including an electric lift arm, 24-Volt motor, wired remote control, emergency button, mechanical emergency lowering, extensible undercarriage pedal, swivel castors and rear-wheel brakes. When a patient is required to be switched to the upright position, he/she is supported by Velcro sheaths in the thoracolumbar area, knees are locked with knee supports, feet are switched to the dorsiflex position using the foot pedal and the patient is brought to the upright position. During this time, the patient grips the lift handles with his/her hands for support. The patient is protected against falling during the lifting process by the brake-lock system.
The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility.
The clinical mobility scale evaluates the level of mobility and is scored between 0 and 3 points. It includes the following items: upright posture, walking, gait, sitting, stair climbing, hand-held appliances and wheelchair and time usage. It is scored between 0 and 24 points, and higher scores indicate increased mobility.
The Barthel index scores daily life activities. The total score can range between 0 and 100 points, with each question score ranging from 0.5 to 10 points. The sub-topics covered include feeding, bathing, grooming, dressing, bowel care, bladder care, toilet use, transfer (bed to chair and back), mobility (on levelled surfaces) and stair climbing. Higher scores indicate improved independence of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups. Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: ExperimentalExperimental group, in which a physical therapy programme supplemented by the James lift system was applied |
| Control | Placebo comparator | Device: ExperimentalControl group, in which a conventional physical therapy programme was applied. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergone surgical procedures leading to immobilisation
- having a disease affecting the musculoskeletal system
- being conscious and not having sitting balance.
Key exclusion criteria (2 listed)
- co-operation, orientation
- cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: ControlConventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase. | Device | Control, Experimental group |
Primary outcome
Mobility index
Time frame: 1 minute
The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility
1 secondary outcome
Daily life activities
Time frame: 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomri̇s Duymaz principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Inpatient Facililty Diagnoses, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility index (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.